Module 3: Quality (Chemistry, Manufacturing & Controls)

Module 3 is the CMC Bible of the eCTD dossier. It houses every piece of quality evidence for both the drug substance (API) and the finished drug product — from synthesis route and characterisation through specifications, analytical validation, and stability. Regulatory statistics show that approximately 60 % of first-cycle deficiency letters cite Module 3 gaps, making it the single largest source of filing rejections worldwide. Mastering its structure is therefore non-negotiable for any RA professional.